Cardiac Rehabilitation in Chagas Heart Failure

Chagas Disease Clinical Trial

Official title:

Cardiac Rehabilitation Program in Patients With Chagas Heart Failure: a Pilot Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02516293
• Other study ID #: CAAE 0055.0.009.000-11
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: July 31, 2015
• Last updated: August 3, 2015
• Start date: May 2013
• Est. completion date: December 2014

Study information

• Verified date: August 2015
• Source: Evandro Chagas National Institute of Infectious Disease
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: Fundacao Oswaldo Cruz
• Study type: Interventional

Clinical Trial Summary

Due to the lack of information in the literature about the role of cardiac rehabilitation on Chagas heart failure, the aim of the present study was to evaluate the effects of a cardiac exercise program on functional capacity, cardiac function, respiratory muscle strength, body composition, biomarkers and quality of life among Chagas heart failure patients.

Description:

The present study consisted in a pre/post single-arm intervention study conducted at the Evandro Chagas National Institute of Infectious Disease (INI), located on Rio de Janeiro, Brazil. INI is a national reference center for treatment and research in infectious diseases and tropical medicine in Brazil, which follows a large cohort of patients with Chagas disease, all of them diagnosed by two simultaneously positive serological tests (enzyme-linked immunosorbent assay and indirect immunofluorescence). Patients included in the study were submitted to a physical exercise intervention protocol performed three times per week, 60 minutes per session, during an 8-month period. Nutritional and pharmaceutical counseling were also monthly provided during the follow-up and consisted on general guidance about adequate eating habits for patients with heart failure, mainly sodium and water intake, and medication usage, particularly drug dosage and compliance.Patients included in the study were followed during an 8-month period in which evaluations of functional capacity (maximal progressive cardiopulmonary exercise test), muscle respiratory strength (manovacuometry) and body composition (anthropometry and skinfolds) were performed at baseline, after four months and at the end of follow-up. Assessments of cardiac function (bidimensional echocardiography), biomarkers (lipid profile, glucose and glycated hemoglobin) and quality of life (Minnesota Living with Heart Failure questionnaire) were taken at baseline and after eight months of follow-up.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: December 2014
• Est. primary completion date: January 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients at the stages C or D of Chagas cardiomyopathy

• Patients receiving standard optimized medical therapy

• Patients with good adherence to outpatient treatment within the last three months.

Exclusion Criteria:

• Those who were not able to attend three weekly training sessions,

• Those who had neuromuscular limitations, cardiopathies from non-Chagasic etiology (e.g ischemic), systemic conditions that limits exercise practice (e.g chronic obstructive pulmonary disease)

• Practitioners of regular exercise.

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cardiomyopathies
• Chagas Cardiomyopathy
• Chagas Disease

Intervention

Behavioral:
• Exercise, nutritional and pharmaceutical counseling
Physical exercise intervention protocol was performed three times per week, 60 minutes per session, during 8 months. Exercise sessions consisted of 30 minutes of aerobic exercise on a treadmill or on a cycle ergometer, 20 minutes of strength exercises for the major muscle groups (sit-ups, push-ups, and pull-ups), and 10 minutes of stretching exercises. Nutritional and pharmaceutical consisted on general guidance about adequate eating habits for patients with heart failure, mainly sodium and water intake, and medication usage, particularly drug dosage and compliance.

Locations

Country	Name	City	State
Brazil	Evandro Chagas National Institute of Infectious Disease	Rio de Janeiro	RJ

Sponsors (1)

Lead Sponsor	Collaborator
Evandro Chagas National Institute of Infectious Disease

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Functional Capacity (VO2 max)	VO2 max (ml/kg/min)	Change from baseline at 4 and 8 months	No
Secondary	Muscle respiratory strength (maximal inspiratory pressure and maximal expiratory pressure)	Maximal inspiratory pressure and maximal expiratory pressure (cm H2O)	Change from baseline at 4 and 8 months	No
Secondary	Body composition (body fat percentage)	Body fat percentage (%)	Change from baseline at 4 and 8 months	No
Secondary	Cardiac function (mainly ejection fraction)	Ejection fraction (%)	Change from baseline at 8 months	No
Secondary	Biomarkers (lipid profile and glucose)	Total cholesterol, Triacylglycerol, HDL-cholesterol, LDL-cholesterol, VLDL-cholesterol (mg/dl) and glucose (mg/dl)	Change from baseline at 8 months	No
Secondary	Biomarkers (glycated hemoglobin)	Glycated hemoglobin (%)	Change from baseline at 8 months
Secondary	Quality of life by Minnesota Living with heart failure questionnaire (MLHFQ)	MLHFQ Score ranging from 0 to 105	Change from baseline at 8 months	No
Secondary	Anthropometry	Body weight (kg)	Change from baseline at 4 and 8 months	No
Secondary	Anthropometry	Waist and hip circumference (cm)	Change from baseline at 4 and 8 months	No